Catheter with valved fluid reservoir

ABSTRACT

In a self-inflating catheter provided with a reservoir of fluid under pressure, the reservoir is provided with internal slit valves, opening by distortion under digital pressure, to control the flow of inflating fluid.

United States Patent Taylor [451 July 11, 1972 [54] CATHETER WITH VALVEDFLUID RESERVOIR [56] References Clted [72] Inventor: Glenn N. Taylor,Barrington, lll. UNITED STATES PATENTS [73] Assignee: The KendallCompany, Boston, Mass. 3,190,291 6/1965Foley..l.........u................ l28/349 BV 3,275,00l 9/1966 Rosecrans...l28/349 EN [221 SellL 3-1970 274,447 3/l883 Kennish ..2sm43 2| A l. N69 3 I 1 pp 0 ,34 Primary Examiner-Dalton L. Truluck Related us.Application mu F y [63] Continuation-impart of Ser. No. 767,296, June14. [57] ABSTRACT In a self-inflating catheter provided with a reservoirof fluid under pressure, the reservoir is provided with internal slit[52] 0.8. CI. ..l28/349 BV, 25 H4, 25 l/l43 valves. p g y distortionunder digital pressure to Comm [5]] Int. Cl. .,A6lm 25/00 the nowofinflafing fluid (58] Field of Seareh............128/348. 349 B, 349BV, 350 R,

l28/35l, 344, 325, 246; 251/4, I43

zcm s DrnwlngFlgum CATHETER \VITH VALVED FLUID RESERVOIR This is acontinuation-in-part of my application Ser. No. 767,296, filed Oct. [4,1968, now abandoned. This invention relates to improvements in thestructure of control valves for regulating the flow of inflation fluidin a catheter having a sterile, self-contained inflating means.

As set forth in U. S. Pat. No. 3,275,001, a catheter of the Foley typeis provided with a fluid reservoir, under pressure, in such a fashionthat by opening a reservoir valve at the desired moments, a part of thecontents of the reservoir is expelled through a passageway or lumen toinflate a balloon placed near the distal end of the catheter. Suchself-contained inflation devices are considered as an improvement overthe conventional type of Foley catheter wherein sterile fluid must beintroduced into the balloon by a hypodermic syringe at the time wheninflation is desired.

For maximum utility the fluid must be retained under pres sure in thereservoir until the catheter is in the desired position for inflation ofthe balloon to convert it to a retention-type catheter. This requires avalve arrangement, controllable at will by the operator, at or near themouth of the reservoir.

Various valve arrangements have been proposed, from external metalclamps closing the reservoir outlet to manipulatable valves placedwithin the lumen connecting the pressurized reservoir with the balloon.Inner valves of the latter type heretofore proposed include blockingdisks of resilient material which must be angularly displaced bypressure, or plugs which are temporarily sealed to the inner wall of theinflating lumen and must be displaced by twisting or stretching thelumen to break the adhesive bond.

External metal clamps are hard to open and provide an encumbrance to theneat and convenient packaging of self-inflating catheters in sealed andsterilized units. Nevertheless, although inner valves are verydesirable, the inner valves proposed in the prior art have been sodeficient in reliability or so difficult to open that present cathetersof the self-inflating type are almost universally provided with externalmetal clamps, despite their undesirable features.

It is with improvements in the art of providing reliable and readilyopened internal fluid control valves for self-inflating catheters thatthe present invention is concerned. It is an object of the invention toprovide such a valve, capable of governing the flow of fluid from apressurized fluid reservoir by the simple application and release ofdigital pressure on the appropriate portion of the lumen which connectsthe reservoir with the balloon.

The invention will be better understood with reference to the followingdescription and the drawings, in which:

FIG. 1 is a schematic view, partially broken away, of a prior artcatheter of the type to which the present invention relates.

FIG. 2 is a cross-sectional view of a pressurized fluid reservoircontaining one embodiment of the valve of this invention, in closedposition.

FIG. 3 is a cross-sectional view of the outlet end of the reservoirshowing the valve under pressure and in an open position.

FIG. 4 is a cross-sectional view of another valve modification of thisinvention.

FIG. 5 is a cross-sectional view of the valve of FIG. 4, under pressureand in open position.

FIG. 6 is a cross-sectional view of another embodiment of the inventionwherein both ends of the reservoir are provided with internal valves.

Referring to FIG. I, a conventional self-inflating catheter 10 is shownas comprising a resilient flexible hollow plastic tube 12 with distalportion 14 and proximal portion 13. The catheter is also provided with asidearm tube 11, terminating in an enlargement l8, constituting a fluidreservoir, within which a fluid such as sterile water is contained. Thereservoir is provided with an outlet portion 21, through which fluid canpass into he lumen of the sidearm tube 11 to inflate the balloon 16 inthe distal portion of the catheter to its inflated configuration asshown by the dotted lines. The lumen connecting the fluid with theballoon is conventional and is not shown. The pressurized reservoir 18is also provided with an inlet portion 24, through which the fluid isconveniently introduced into the reservoir at the time the catheter isreadied for use. The inlet portion is conventionally gnovided with asocalled Gilbert plug consisting of a plug of soft resilient rubber 26with an inner lumen 28. Customarily the reservoir 18 is filled withfluid under pressure by the introduction of a hypodermic needle throughthe lumen of the plug and through the solid wall portion thereof. Upondischarge of the fluid into the reservoir and subsequent withdrawal ofthe needle, the self-sealing nature of the plug confines the fluid inthe reservoir. The outlet end 21 of the reservoir is maintained in aclosed position by a metal or plastic clamp of clip 22, which constrictsthe lumen of the sidearm tube 1 l. The structure set forth above isprior art.

FIG. 2 represents an embodiment of the present invention where theobjectionable external clamp 22 of FIG. 1 has been replaced by as easilymanipulatable inner valve 42 placed in the outlet portion 38 of thepressurized fluid reservoir. In more detail, the reservoir 30 with walls32 contains sterile fluid 34 under pressure. The inlet portion 36 of thereservoir is closed by the Gilbert plug 37. The outlet portion 38 of thereservoir is closed by means of a slit valve 42, of a resilient.deformable plastic material, which may be of the same material as themain body of the catheter: that is, of rubber or a rubber-like syntheticelastomer. The valve 42, as shown, is in the shape of one half of atubular capsule open at one end and closed at the other, but providedwith a slit which is cut completely through a portion of the wall of thevalve and which hence is capable of being opened by distortion whenexternal pressure is applied. In stand-by configuration, the slit isclosed and the fluid 34 is thereby prevented from flowing into the lumen40 of the sidearm. The valve 42 is peripherally sealed by an adhesive inthe inner wall of the sidearm, as shown by the adhesive deposit 43.Alternatively, the valve may be stabilized in position by an externalconstricting ring, or by a tight fit with the inner wall of the cathetersidearm.

The slit valve 42 is shown in FIGS. 2 through 6 in its preferredlocation: that is, with the outlet portion 38 of the reservoirconstituting a cylindrically shaped elongation of the reservoir 30. Suchan arrangement affords the operator the maximum facility in locating anddilating the valve 42. However, it is also possible to seal the valve 42directly into the outlet portion of a generally spherical reservoir,provided that the slit portion of the valve is free from contact withthe walls of the reservoir.

When pressure is applied to the outlet portion of the reservoir, as atthe points 39-39, the valve 42 is compressed, opening the slit 44 to theconfiguration shown in FIG. 3. This allows the pressurized fluid to flowout of the reservoir and into the lumen 40 of the sidearm tube, therebyfulfilling its function of inflating the retention balloon. Due to theresilient nature of the elastomeric plug 42, the slit 44 may be openedby digital pressure as exerted by squeezing the opening portion 38 ofthe reservoir between the thumb and forefinger, or much moreconveniently than by opening the prior art metal clamps, which is anoperation requiring both hands.

To insure proper functioning, the fluid pressure in the filled reservoirmust exceed the pressure needed to inflate the retention balloon, andthe slit valve must withstand that pressure until it is opened bymanipulation. The retention balloon inflation pressure varies from 8 to9 pounds per square inch to 14 pounds per square inch, depending on thesize of the catheter. Normally, to promote proper inflating of theballoon portion, the reservoir of the catheter is filled with between 5and is cubic centimeters of water, under a pressure of between 10 and 30pounds per square inch. In order to prevent leakage, it has been foundthat slit valve 42 should have a wall thickness of between 0.065 and0.090 inches. Valves of this wall thickness resist opening under theoperative water pressures, yet open readily under digital manipulation.

Considerable latitude may be exerted in the placement of the slit 44 inthe elastomeric slit valve 42. In FIGS. 4 and 5 a slit valve, in closedand open positions, is shown wherein the slit 44 is made horizontallythrough the closed tip of the valve. rather than vertically through theupper wall as in FIGS. 2 and 3. The operation of the valve issubstantially the same. with pressure applied at the points 39-39 ofFIG. 4 causing the deformable elastomeric valve 42 to assume theconfiguration shown in FIG. 5.

If desired, a slit valve may replace the conventional Gilbert plug inthe inlet portion of the pressurized reservoir, as well as in the outletend. Such an arrangement is shown in FIG. 6, where a slit valve 46, withslit 48, is adhesively bonded by adhesive 47 to the inner wall of theinlet lumen 50, or mechanically stabilization a set forth above. Whenthe inlet portion 36 of the reservoir is compressed, the slit 48 in theslit valve 46 is opened, allowing fluid under pressure to be introducedthrough the lumen 50 to pressurize the reservoir 30. When the desiredamount of fluid has been introduced, release of pressure on the inletportion of the reservoir causes the slit valve to close. In this manner,when a retention catheter with an inflated balloon is to be removed, theapplication of digital pressure simultaneously at the inlet and outletends of the reservoir will open both deformable slit valves, thusallowing the balloon to collapse and fluid to drain therefrom.

Having thus described my intention, I claim:

1. In a retention-type catheter containing a self-inflating 4 mechanismcomprising a reservoir filled with fluid under pressure,

said reservoir having an outlet portion connected by a lumen to aninflatable retention balloon situated in the distal end of saidcatheter,

and a substantially oppositely-placed inlet portion,

that improvement which comprises the provision in at least the outletportion of said reservoir of a soft. resilient hollow cylindrical slitvalve with one closed end,

the closed end of said valve being oriented toward said reservoir,

the closed end of said valve containing a slit which opens by distortionupon the application of digital pressure on the side walls of said valveand closes upon the release of said pressure,

the fluid presure in the reservoir being in excess of the pressureneeded to inflate the retention balloon but less than the pressureneeded to open said slit valve.

2. A catheter according to claim 1 in which a pair of resilient slitvalves of the type described therein are fixed into both the inlet andthe outlet portions of the reservoir, the closed ends of both valvesbeing oriented toward said reservoir.

II I! i l k

1. In a retention-type catheter containing a self-inflating mechanismcomprising a reservoir filled with fluid under pressure, said reservoirhaving an outlet portion connected by a lumen to an inflatable retentionballoon situated in the distal end of said catheter, and a substantiallyoppositely-placed inlet portion, that improvement which comprises theprovision in at least the outlet portion of said reservoir of a soft,resilient hollow cylindrical slit valve with one closed end, the closedend of said valve being oriented toward said reservoir, the closed endof said valve containing a slit which opens by distortion upon theapplication of digital pressure on the side walls of said valve andcloses upon the release of said pressure, the fluid pressure in thereservoir being in excess of the pressure needed to inflate theretention balloon but less than the pressure needed to open said slitvalve.
 2. A catheter according to claim 1 in which a pair of resilientslit valves of the type described therein are fixed into both the inletand the outlet portions of the reservoir, the closed ends of both valvesbeing oriented toward saId reservoir.